- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06480851
Effectiveness of Percutaneous Neuromodulation in the Treatment of Cervical Pain in University Students.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Boadilla del Monte, Madrid, Spain, 28668
- San Pablo CEU University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Current Cervical Pain on a Visual Analog Scale (VAS) greater than 3.
- Neck pain in the last 12 weeks, and no treatment has been performed.
- Disability index of 8% or more on the Neck Disability Index.
- That they have undergone treatment.
Exclusion Criteria:
- Neck pain associated with vertigo.
- Osteoporosis (control X-ray).
- Diagnosed psychological disorders.
- Vertebral fractures (control X-ray).
- Tumors.
- Diagnosed metabolic diseases.
- Neck surgery.
- Belonephobia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neck Pain Group
|
Ecoguided Percutaneous Neuromodulation over the posterior branch of the cervical multifidus, for 10 minutes, with a frequency of 10 HZ.
|
|
Active Comparator: Non Neck Pain Group
|
Ecoguided Percutaneous Neuromodulation over the posterior branch of the cervical multifidus, for 10 minutes, with a frequency of 10 HZ.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain threshold
Time Frame: up to 1 Week
|
Portable hand pressure algometer (FPX 50/220, Wagner Instruments, Greenwich, USA), measured in kg / cm² (kilogram per centimeter squared).
|
up to 1 Week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-related quality of life
Time Frame: Baseline
|
The Short Form Health Questionnaire (SF-36) questionnaire, which examines health-related quality of life under eight sub-titles; It consists of 36 items.
The SF36 questionnaire will be used in the study.
|
Baseline
|
|
Pain by visual analog scale
Time Frame: Baseline
|
usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)
|
Baseline
|
|
Pain by visual analog scale
Time Frame: after intervention
|
usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)
|
after intervention
|
|
Pain by visual analog scale
Time Frame: Follow-up at 1 week
|
usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)
|
Follow-up at 1 week
|
|
Neck Disability Index Questionnaire.
Time Frame: Baseline
|
Quantification of pain and disabilty
|
Baseline
|
|
Neck Disability Index Questionnaire.
Time Frame: after intervention
|
Quantification of pain and disabilty
|
after intervention
|
|
Neck Disability Index Questionnaire.
Time Frame: Follow-up at 1 week
|
Quantification of pain and disabilty
|
Follow-up at 1 week
|
|
Kinesiophobia
Time Frame: Baseline
|
Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version.
Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.
|
Baseline
|
|
Kinesiophobia
Time Frame: after intervention
|
Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version.
Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.
|
after intervention
|
|
Kinesiophobia
Time Frame: Follow-up at 1 week
|
Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version.
Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.
|
Follow-up at 1 week
|
|
Pain Catastrophizing Scale
Time Frame: Baseline
|
Pain Catastrophizing Scale (PAS) will be used to evaluate the participants' pain-related thoughts and feelings.
|
Baseline
|
|
Pain Catastrophizing Scale
Time Frame: after intervention
|
Pain Catastrophizing Scale (PAS) will be used to evaluate the participants' pain-related thoughts and feelings.
|
after intervention
|
|
Pain Catastrophizing Scale
Time Frame: Follow-up at 1 week
|
Pain Catastrophizing Scale (PAS) will be used to evaluate the participants' pain-related thoughts and feelings.
|
Follow-up at 1 week
|
|
Health-related quality of life
Time Frame: after intervention
|
The Short Form Health Questionnaire (SF-36) questionnaire, which examines health-related quality of life under eight sub-titles; It consists of 36 items.
The SF36 questionnaire will be used in the study.
|
after intervention
|
|
Health-related quality of life
Time Frame: Follow-up at 1 week
|
The Short Form Health Questionnaire (SF-36) questionnaire, which examines health-related quality of life under eight sub-titles; It consists of 36 items.
The SF36 questionnaire will be used in the study.
|
Follow-up at 1 week
|
|
Sonoelastography
Time Frame: Baseline
|
This diagnostic test would be executed by a Physiotherapist who has experiences of using General Electric, P9 model ultrasound system for more than three year. The equipment to obtain the image will be used with a frequency of 12 MHz, 22 dB gain, 85 dynamic range, brightness at 17 and depth of 4 cm. The transducer will be placed on the spinosa of C4 and the probe will be moved towards the transverse of each of the sides, to identify the image of the multifidus muscle in depth. Once the muscle is located in this segment, a longitudinal and transverse image of the muscle will be obtained, performing the elastography at the same time and calculating the elastographic values (tissue resistance in kilopascals and transmission speed in meters/second). |
Baseline
|
|
Sonoelastography
Time Frame: after intervention
|
This diagnostic test would be executed by a Physiotherapist who has experiences of using General Electric, P9 model ultrasound system for more than three year. The equipment to obtain the image will be used with a frequency of 12 MHz, 22 dB gain, 85 dynamic range, brightness at 17 and depth of 4 cm. The transducer will be placed on the spinosa of C4 and the probe will be moved towards the transverse of each of the sides, to identify the image of the multifidus muscle in depth. Once the muscle is located in this segment, a longitudinal and transverse image of the muscle will be obtained, performing the elastography at the same time and calculating the elastographic values (tissue resistance in kilopascals and transmission speed in meters/second). |
after intervention
|
|
Sonoelastography
Time Frame: Follow-up at 1 week
|
This diagnostic test would be executed by a Physiotherapist who has experiences of using General Electric, P9 model ultrasound system for more than three year. The equipment to obtain the image will be used with a frequency of 12 MHz, 22 dB gain, 85 dynamic range, brightness at 17 and depth of 4 cm. The transducer will be placed on the spinosa of C4 and the probe will be moved towards the transverse of each of the sides, to identify the image of the multifidus muscle in depth. Once the muscle is located in this segment, a longitudinal and transverse image of the muscle will be obtained, performing the elastography at the same time and calculating the elastographic values (tissue resistance in kilopascals and transmission speed in meters/second). |
Follow-up at 1 week
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEU-026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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